Breaking barriers in biologic formulation development through collaboration

Summary 

• Excipients are essential for advancing biologic drug development, helping to address key formulation challenges. But their limited availability for parentally administered biologics can hinder innovation. 
• To address this gap, dsm-firmenich and ten23 health have joined forces to help expand excipient options for parenteral formulations, supporting more stable, reliable biologic drug products. 
• Keep reading to explore how this collaboration is unlocking new solutions for biologics, accelerating development, and ultimately ensuring patients have access to critical therapies.

From James Watson and Francis Crick’s discovery of the structure of DNA to Pfizer and BioNTech’s collaboration on the COVID-19 vaccine—partnerships in the pharmaceutical industry have always been a lever to success. And their importance is only growing over time. As therapies become more sophisticated, the challenges associated with bringing them to market are becoming equally complex. Breakthroughs and overcoming persistent technical challenges increasingly rely on expertise that spans multiple disciplines, from ingredient science and formulation development to regulatory strategy and manufacturing. This is certainly true for advanced biologic medicines.

An ongoing barrier in the development of biologics is the small number of excipients approved for parenteral use, making it difficult for drug developers to fully address the formulation challenges associated with these therapies. To help close this gap, dsm-firmenich has entered a research partnership with ten23 health—a specialist in sterile pharmaceutical drug products—to evaluate and develop regulatory-ready excipient options for parenteral biologic drug development. In this article, we explore how our joint expertise could open the door to more reliable biologic medicines and ultimately improve patient access to these critical therapies. 

Expanding the toolbox for biologic formulations

Excipients are critical to the success of any therapeutic—yet very few are approved for parenterally administered biologics across global markets. This is largely because the use of new excipients in biologic formulations requires extensive safety assessments and regulatory processes, which can restrict innovation and limit the ability to fully address formulation challenges, like stability. When these issues are not effectively addressed, product quality may be compromised, which could impact safety and efficacy. This means that potentially groundbreaking medications cannot have the impact they were designed to deliver. 

Let’s take a marketed monoclonal antibody trastuzumab as an example. Its formulation typically relies on excipients like histidine, sucrose, and polysorbates. But even with these established ingredients, trastuzumab is sensitive and at risk of challenges such as pH sensitivity, heat-induced degradation, and protein aggregation.^1,2To overcome these issues, specific excipients are needed—however, because there are very few approved for injectable biologics, formulators have limited tools to optimize these formulations. As such, there is an exciting opportunity to widen the availability of excipients to give developers more flexibility (and success)—and that’s exactly what we’ve set out to achieve with ten23 health.

A partnership built on complementary expertise

ten23 health brings its capabilities in biologic formulation development, sterile manufacturing, and analytical testing to the table. Whereas we provide deep expertise in ingredient science, along with the quality and regulatory documentation needed to support pharmaceutical applications from the earliest stages of development. Through our expertise and services, we can help pharmaceutical developers meet stringent industry standards and navigate complex regulatory landscapes with confidence.

“We saw a clear opportunity to address one of the most persistent challenges in biologic development: the limited range of excipients approved for parenteral use,” explains Dr. Estel Canet Martinez, Associate Innovation Director Pharma at dsm-firmenich. “Together with ten23 health, we are evaluating pharmaceutical-grade ingredients with established safety profiles to understand how they perform in complex biologic formulations. Our goal is to identify solutions that enhance stability and functionality, helping to expand the current excipient toolbox. At the same time, we will ensure that every ingredient meets the highest pharmaceutical standards, including purity, stability, and GMP-grade quality, while carefully considering regional regulatory requirements.”

Enabling more robust biologic drug products

Explaining how they will approach the project, Prof. Dr. Andrea Allmendinger, Chief Scientific Officer at ten23 health explains: “So far we have selected ingredients based on their safety profiles, regulatory acceptance, and practical considerations such as solubility and intrinsic stability, and conducted proof-of-concept studies to evaluate their performance against application-specific criteria, often benchmarking them against industry-standard excipients. Promising candidates were then further assessed in representative protein matrices using advanced analytical techniques to determine their ability to address key stability challenges, such as protein aggregation or excipient degradation. So far, we have generated promising initial data, which is now being further verified.”

Although our collaboration is still in its early stages, its potential implications for biologic drug development are significant. By expanding the range of excipients available to formulators, we can help them address key formulation challenges and improve product stability and shelf-life, supporting more robust manufacturing and distribution processes. This can in turn help simplify supply chains, reduce development timelines, and support more reliable access to critical medicines. What’s more, by expanding ingredient options and improving formulation flexibility, we want to empower developers to design medicines that better meet patient needs—whether that’s more convenient dosing, improved tolerability, or formats tailored for self-administration.

Trusted partnerships as a catalyst for innovation

As biologic medicines continue to evolve, so too must the tools and expertise required to develop them, making collaboration essential. The partnership we’ve created with ten23 health demonstrates how together, we can help biologic formulation developers design more stable and reliable drug products while reducing development risks.

“Our partnership has the potential to set a new precedent for how ingredient suppliers and formulation experts work together—moving beyond transactional relationships to true co-development,” says Dr. Estel Canet Martinez. “By sharing data and expertise, and making collaboration the norm for tackling complex formulation challenges, we can help accelerate pharmaceutical innovation. In the long run, this could support a shift toward more personalized, accessible therapies, benefiting patients with diverse requirements and conditions.”

Bringing progress to life through responsible collaboration

As biologic medicines continue to evolve, so too must the tools and partnerships that support their development. The collaboration between dsm-firmenich and ten23 health reflects a shared commitment to advancing excipient options in a way that combines innovation, quality, and responsibility. By aligning deep ingredient expertise with state-of-the-art formulation and testing capabilities, the partnership is helping to expand what is possible in biologic drug development—supporting more stable, reliable formulations and more efficient development pathways.

Importantly, this work is underpinned by a commitment to responsible and efficient scientific practices, from sourcing and manufacturing through to laboratory operations, ensuring progress in biologics is achieved with long-term sustainability in mind. Ultimately, the collaboration demonstrates how shared expertise and sustainability values can help unlock the next generation of biologic therapies—bringing better, more reliable treatments closer to the patients who need them.